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| ID | Type | Description | Link |
|---|---|---|---|
| 5T32HD068223-13 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this clinical trial is to learn if a telehealth intervention (Surviving and Thriving in the Real World; STRW) is helpful to improve daily living skills for teens and young adults with epilepsy. It will also learn about the acceptability, feasibility, and satisfaction of the intervention. The main questions it aims to answer are:
This is a nonrandomized pilot trial and all participants who enroll will:
Epilepsy is a common childhood neurological condition and disproportionately affects adolescents and young adults (AYAs) compared to younger children. An estimated 1.1 million AYAs with epilepsy will become adults and with this transition to adulthood, youth with epilepsy often have increased challenges, including social stigma, reduced health-related quality of life, and perceived lack of independence. Some of these challenges may be related to deficits in executive functioning (EF), and as many as 30-50% of AYAs with epilepsy demonstrate EF deficits. EF has also been shown to impact adaptive functioning. Daily living skills (DLS), a component of adaptive functioning, are essential for managing independent living into adulthood. Age-appropriate DLS are linked to better adult outcomes in youth, including finding and keeping a job, attending college, and living independently. However, research has shown that even with relatively normal cognitive abilities, youth with epilepsy have demonstrated poorer adaptive skills compared to same-age peers, and interventions targeting the acquisition of DLS may be an important mechanism for closing this gap. Surviving and Thriving in the Real World (STRW) is a 15-week evidence-based DLS intervention developed originally for adolescents with autism without an intellectual disability (ID; IQ>70) that has shown promising results for improving DLS. Given the overlap of deficits in adaptive and executive functioning, STRW may be a useful intervention for adolescents with epilepsy to improve DLS in a structured and supported program prior to their transition to adulthood. In the current study, the investigators will deliver STRW for adolescents with epilepsy and test the effectiveness of the virtual intervention with families recruited from Cincinnati Children's Hospital Medical Center (CCHMC). Given the emphasis on increasing DLS for adolescents with challenges in adaptive functioning, adolescents will be screened based on a parent measure of adaptive functioning skills called the Adaptive Behavior Assessment System, Third Edition (ABAS-3) prior to intervention enrollment. The aim is to assess the satisfaction and acceptability of the STRW intervention for caregivers and adolescents completing the intervention and to determine the impact on adaptive functioning from pre- to post-treatment. The intervention will enroll high schoolers (i.e., 9th-12th graders) to examine the impact of the intervention on youth prior to the transition to adulthood. The investigators expect that adolescents and caregivers will rate STRW as satisfactory and acceptable and youth who complete the STRW intervention will demonstrate improvements on the caregiver-reported primary DLS assessment (ABAS-3) from pre-to post-treatment. Adolescent-reported DLS will also be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surviving and Thriving in the Real World | Experimental | Participants in this single arm receive the study intervention (Surviving and Thriving in the Real World (STRW)). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surviving and Thriving in the Real World | Behavioral | The Surviving and Thriving in the Real World (STRW) intervention consists of 15 weekly caregiver-teen dyad sessions and 14 concurrent weekly caregiver group sessions delivered via Microsoft Teams. Daily Living Skills (DLS) targeted in the intervention include: morning routine, laundry, kitchen/cooking, grocery shopping, and money management. Evidence-based strategies are utilized to facilitate acquisition, mastery, and generalization of specific DLS at home and in the community. During dyad sessions, teens work on DLS in their home environment and will receive coaching and instruction from both their caregiver and the therapist. During caregiver group sessions, the therapist will discuss the content of dyad sessions and engage in problem solving with each caregiver. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Enrollment rate will be calculated by dividing the number of consented participants by the number of eligible participants. | Enrollment |
| Retention Rate | Retention will be calculated by dividing the number of participants who completed the study at post-treatment by the number of eligible participants enrolled. | From enrollment to 1-month post intervention (up to approximately 23 weeks) |
| Caregiver Satisfaction and Acceptability | The study-specific satisfaction and acceptability surveys will be sent to caregivers after each caregiver group and dyad session attended in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial. | Weekly during the intervention (Up to 15 weeks) |
| Adolescent/Young Adult Satisfaction and Acceptability | The study-specific satisfaction and acceptability surveys will be sent to adolescent and young adult participants after each dyad session completed in order to obtain timely feedback on aspects of the intervention. For each item, participants are asked to rate helpfulness of each treatment component on a 5-point scale with 1 indicating "not helpful" and 5 indicating "very helpful." Mean ratings across all sessions will be utilized to determine satisfaction and acceptability, with a mean of 4 or higher indicating overall satisfaction and acceptability in the trial. | Weekly during the intervention (Up to 15 weeks) |
| Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Other (Caregiver) Form, Practical Domain Standard Score |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive Behavior Assessment System, Third Edition (ABAS-3), Adult-Self Form, Practical Domain Standard Score | The ABAS-3 Adult-Self Form, Practical Domain Standard Score will be used as a secondary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills. |
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Inclusion Criteria:
Exclusion Criteria:
Parent- or clinician-reported history in the adolescent/young adult of:
Clinician-reported diagnosis in the adolescent/young adult of:
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| Name | Affiliation | Role |
|---|---|---|
| Avani Modi, Ph.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| Label | URL |
|---|---|
| STRW Website | View source |
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Individual Participant Data (IPD) will not be made available. Given the very small sample size of this pilot study, there is a substantial risk of participant re-identification even after de-identification procedures, and therefore data sharing is not appropriate.
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
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The proposed study will involve a single site nonrandomized pilot trial using pre-post design to assess the acceptability, feasibility, and satisfaction of the Surviving and Thriving in the Real World (STRW) intervention with teens and young adults with epilepsy and determine the impact of STRW on daily living skills.
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The ABAS-3 Adult-Other (Caregiver) Form, Practical Domain Standard Score will be used as a primary outcome measure. The standard score is calculated based on the sum of scaled scores for each of the skill areas. The standard scores typically range from 70 to 120, with a mean of 100 and a standard deviation of 10. Higher scores equate to better adaptive skills. |
| Post-Intervention (Up to 4 weeks Post-Intervention) |
| Post-Intervention (Up to 4 weeks Post-Intervention) |